Reaction mass of fatty acids, montan-wax, 1-methyl-1,3- propanediyl esters and fatty acids, montan-wax, ethylene esters and fatty

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

20 Jul 2005 to 2 Aug 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD 405, EU B.5)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Remarks:

in compliance with the Swiss legislation an Good Laboratory Practice

Test material

Test material information

Constituent 1

Reference substance name:

Montan waxes, type CaV 102

IUPAC Name:

Montan waxes, type CaV 102

Details on test material:

- Name of test material (as cited in study report): Licomont CaV 102 Fine Grain
- Substance type: Slightly yellow powder
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: At room temperature (range of 20 ± 5 °C), Iight protected

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kisslegg, Germany
- Age at study initiation: 11-12 weeks
- Housing: Individually in stainless steel cages
Diet (ad libitum): standard Provimi Kliba 3418 rabbit maintenance
diet (batch no. 22/05) (Provimi Kliba AG, Kaiseraugst, Switzerland)
- Water (ad libitum): Community tap water
- Acclimation period: 4-5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as internal control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

72 h

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 of mixed sex

Details on study design:

SCORING SYSTEM: according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004, at approximately 1, 24, 48 and 72 hours, as well as 7 days after instillation.

TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp (Roth AG Reinach, Switzerland)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed at any time point

Remarks on result:

other: scores of individual animals: 0.0, 0.0, 0.0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects observed at any time point

Remarks on result:

other: scores of individual animals: 0.0, 0.0, 0.0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: scores of individual animals: 0.67, 0.0, 0.33

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed at any time point

Remarks on result:

other: scores of individual animals: 0.0, 0.0, 0.0

Irritant / corrosive response data:

No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals.
Slight to moderate reddening of the conjunctivae was noted in all animals one hour after treatment and slight reddening persisted up to the 24- or 48-hour reading in two animals, respectively.
Slight reddening of the sclerae was present at the 1-hour reading in one animal.
No abnormal findings were observed in the treated eye of any animal 72 hours after treatment, the end of the observation period for all animals.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the test item was not irritating to the eye of rabbits.

Executive summary:

The primary eye irritation potential of the test item (Licomont CaV 102 Fine Grain) was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits.

The instillation of the test item into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae. These effects were reversible and were no longer evident 72 hours after treatment. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 days after test item instillation. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.67, 0.00 and 0.33 for reddening and 0.00 for chemosis for all animals, respectively.

Thus, the test item did not induce significant or irreversible damage to the rabbit eye.